CTCA Prior to Invasive Angiography in Post-Bypass Patients (BYPASS CTCA 2)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CTCA.
- Who it may be relevant to
- Registry conditions: Coronary Heart Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multi-Centre, Randomised Trial Assessing the Value of Computed Tomography Coronary Angiography Prior to Invasive Coronary Angiography in Patients With Previous Coronary Artery Bypass Grafts in Reducing Cardiac Events
Overview
The goal of this clinical trial is to evaluate whether a coronary computed tomography angiography (CTCA)-guided strategy can reduce the risk of death, heart attack, stroke, and hospital admissions in patients experiencing angina or myocardial infarction following coronary artery bypass graft (CABG) surgery. The main questions it aims to answer are: * Can CTCA reduce major adverse cardiovascular events compared to standard invasive coronary angiography? * Is CTCA a cost-effective and safer alternative that improves patient quality of life? Researchers will compare outcomes between patients receiving CTCA prior to angiography and those undergoing standard angiography alone to determine if CTCA improves clinical outcomes and procedural safety. Participants will: * Be randomly assigned to either CTCA-guided care or standard angiography * Undergo coronary imaging and follow-up assessments * Complete questionnaires on quality of life and healthcare resource use
Detailed description
Patients with prior coronary artery bypass graft (CABG) surgery frequently present with recurrent angina or acute coronary syndromes due to progressive native coronary artery disease or graft failure. Invasive coronary angiography remains the standard diagnostic approach but is technically challenging in this population due to variable graft anatomy, leading to prolonged procedure times, increased radiation exposure, higher contrast volumes, and elevated risk of procedural complications.
Computed Tomography Coronary Angiography (CTCA) offers a non-invasive alternative with high diagnostic accuracy for graft patency and coronary anatomy. Prior observational data (e.g., BYPASS-CTCA study) suggest that CTCA performed prior to invasive angiography may improve procedural efficiency and safety. However, whether CTCA can guide clinical decision-making to avoid unnecessary angiography and improve long-term outcomes remains unproven.
This multi centre, randomised controlled trial will enrol 1,000 patients with prior CABG presenting with angina or myocardial infarction. Participants will be randomised to either a CTCA-guided strategy or standard care involving direct invasive coronary angiography. In the CTCA arm, angiography may be deferred if CTCA findings support medical management. The primary outcome is the composite rate of major adverse cardiovascular events (MACE), including death, myocardial infarction, stroke, and hospitalisation for unstable angina. Secondary outcomes include procedural metrics, patient-reported quality of life, cost-effectiveness, and healthcare resource utilization.
Clinical data will be collected through patient questionnaires, procedural records, and central registry downloads. The study incorporates patient and public involvement throughout its design and implementation. Results will be disseminated via peer-reviewed publications, public-facing reports, and digital platforms.
Interventions
- Diagnostic test CTCA
Computed Tomography Cardiac angiography (CTCA) performed prior to invasive coronary angiogram (ICA).
Primary outcome measures
- Composite major adverse cardiovascular events (MACE): all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, and cardiovascular hospitalisation [Time frame: Up to 2.5 years post-randomisation (median follow-up: 18 months)]
Secondary outcome measures (12)
- Fluoroscopy time during coronary angiography [Time frame: During coronary angiography procedure]
- Incidence of procedural complications during coronary angiography [Time frame: During coronary angiography procedure]
- Radiation dose during coronary angiography [Time frame: During coronary angiography procedure]
- Contrast dose administered during coronary angiography [Time frame: During coronary angiography procedure]
- Procedural duration during coronary angiography [Time frame: During coronary angiography procedure]
- Health-related quality of life (EQ-5D-5L) [Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months]
- Cost-effectiveness and productivity loss [Time frame: Baseline and every 6 months during follow-up]
- Days alive and out of hospital [Time frame: From randomisation until end of follow-up (up to 2.5 years)]
- Length of hospital stay [Time frame: From randomisation until end of follow-up (up to 2.5 years)]
- Major Adverse Cardiovascular Events (MACE) - Individual components [Time frame: From randomisation until end of follow-up (up to 2.5 years)]
- Composite two-point MACE (death and MI) [Time frame: From randomisation until end of follow-up (up to 2.5 years)]
- Major Adverse Cardiovascular Events (MACE) - Cumulative incidence [Time frame: From randomisation until end of follow-up (up to 2.5 years)]
Eligibility criteria
Inclusion criteria
- Aged ≥18
- Previous coronary artery bypass grafting (CABG)
- An indication for coronary angiography
- Angina
- Ischaemia on perfusion imaging
- Acute coronary syndrome
- Patients are able and willing to give their written informed consent
Exclusion criteria
- Subjects presenting with ST segment myocardial infarction within window for primary PCI
- Patients considered unsuitable to participate by the research team (e.g. due to medical reasons, laboratory abnormalities, or subject's unwillingness to comply with all study related procedures)
- Life expectancy less than 1 year
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United Kingdom · 1 center
- St Bartholomew's Hospital — London
Identifiers
NCT: NCT07165678 · 341412 · NIHR207209 · PR2300245